Webinars: Review of key aspects of medical devices and the impact of European regulations

In November 2023, Cratia conducted four webinars, which became key in considering the conformity assessment of medical devices and the impact of the recognition of European certificates on the medical device market in Ukraine.

The first two webinars, held on November 7th and 14th, focused on the fundamentals of conformity assessment. The webinar on November 7 was useful for both importers and distributors, as well as for national manufacturers. Viktoriia Moroz, a Key Account Manager, reviewed the classification of medical devices, conformity assessment procedures, market surveillance, and other key aspects. Participants had free access, allowing for a deeper understanding of conformity assessment procedures.

On November 14th, Maksym Bagrieiev, managing partner, shared crucial insights regarding the influence of Ukrainian requirements and procedures on the understanding of foreign partners. These webinars gained popularity and became the basis for active knowledge exchange.

The remaining two webinars, conducted on November 21st and 24th, focused on the recognition of EU certificates for medical devices in Ukraine. The webinar programs focused on legislative requirements, the extension of the MDR transition period, and the procedure for the recognition of EC MDR and IVDR certificates.

It is worth noting that Ukraine has been conducting the recognition procedure since 2016, which has been in great demand among foreign manufacturers. This has contributed to the development of the country’s medical market and facilitated the entry of foreign manufacturers into the Ukrainian market through conformity assessment by assessing documentation.

All four webinars proved to be essential for authorized representatives in Ukraine, foreign and national manufacturers operating in the Ukrainian medical products market, or those interested in entering it.

These webinars provided participants with valuable information on the legalization of medical products in Ukraine. Our events are conducted in Ukrainian and English, aiming to ensure accessibility and diversity.

If you have any questions, please feel free to contact us via email or phone.

The Cratia Team


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